Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 206426
Company: BIOCRYST
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RAPIVAB PERAMIVIR 200MG/20ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/19/2014 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206426lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206426Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206426Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206426Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/03/2018 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206426s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206426Orig1s005ltr.pdf
09/20/2017 SUPPL-4 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206426s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206426Orig1s004ltr.pdf
08/12/2016 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206426s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206426Orig1s003ltr.pdf
11/02/2016 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/11/2016 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/03/2018 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206426s005lbl.pdf
09/20/2017 SUPPL-4 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206426s004lbl.pdf
08/12/2016 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206426s003lbl.pdf
12/19/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206426lbl.pdf

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